OBJECTIVES: Analyse the price dynamics of adalimumab originator following the reimbursement of adalimumab biosimilar drugs.

METHODS: Data were taken from published official documents (Official Journal [OJ] publications and regional tender reports) from July 2004 up to May 2020 and analysed through an internal excel database, collecting both adalimumab originator and its biosimilars prices over time for a comparable formulation (2 syr. 40mg s.c.).

RESULTS: Up to 2018 the price of adalimumab originator has been rebated several times after Italian Medicines Agency (AIFA) renegotiations due to a number of additional therapeutic indications (from a net price of €993.65 in July 2004 to €841.42 in May 2018 with transparent or hidden discounts ranging from 7.01 to 12.75% and an overall price reduction of 15.32%). Starting from August 2018, four biosimilar drugs have been reimbursed and actually commercialised in Italy (Amgevita®, Imraldi®, Hyrimoz® and Idacio®). In addition to a lower ex-factory price negotiated at central level by AIFA, regional policies and tender procedures have resulted in a considerable decrease of the net price paid by the Italian National Health Service (iNHS), reaching €520.00 per pack (-47.7% compared to 2004 adalimumab originator net price) for adalimumab originator and €87.80 per pack (-91.2% compared to 2004 adalimumab originator net price) for adalimumab biosimilar (Idacio®). As shown from our database, the introduction of biosimilars has also affected the net price of adalimumab originator which now sees the application of a 46,1% discount.

CONCLUSIONS: Our analysis shows the relevance of biosimilars from a market price perspective. While for adalimumab originator AIFA price negotiations (additional therapeutic indications) only had a limited effect, the introduction of biosimilars, due to a competitive effect, has significantly reduced the overall net price of both originator and biosimilars, with understandable benefit for iNHS spending.